As mentioned throughout our newsletter last year, Japan is trying to alleviate its drug lag problem and encourage more drug innovation. On a pilot basis, in an announcement in early September, the MHLW has recently noted that they will accept innovative drug applications in English from foreign drug makers with no presence or agents in Japan. For innovative new drugs, English can be used for registration applications, common technical documents, and draft labels. Foreign companies that wish to do everything in English need to first discuss this first with the Office of Review management of the PMDA.
In addition, the MHLW’s R&D division hopes to set up a new consultation group to help promote multi-regional clinical trials including Japan. Again, for companies with no presence or agents in Japan, foreign drug companies developing innovative drugs will be able to submit inquiries in English. Besides face-to-face meetings in Japan, this group will reply to emails and phone calls in English too. One topic to be discussed will include which hospitals in Japan will be appropriate for new innovative therapies for specific diseases. Finally, the MHLW is also going to undertake a new project involving first-in-human (FIH) studies in Japan. The program wants to establish more innovative drug sites for doing FIH trials, as well as create more GMP-equipped facilities.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.